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WHITE PAPER: The New India Medical Device Rules, 2017

India has made significant strides in the healthcare sector in the past few decades. In 2017, India's regulatory authority - the Central Drug Standard Control Organization (CDSCO) - published the Medical Device Rules, 2017, which came into force as of January 1, 2018. While the regulations brought more structure to India's developing regulatory framework, they also raised a number of questions.

In this white paper, we will discuss the key changes in the regulation and what this means for companies selling their devices in India. You will learn:

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Within the UL family of companies, we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body, and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest, and protection of both our brand and our customers' brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn morehere.